Skip to content

Reactions to Oro-facial Solicitations : a Predictor of Eating Difficulties for Premature Babies of 36 Weeks Gestation Adjusted Age

Reactions to Oro-facial Solicitations : a Predictor of Eating Difficulties for Premature Babies of 36 Weeks Gestation Adjusted Age

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07495709
Acronym
RESOF-36
Enrollment
80
Registered
2026-03-27
Start date
2026-04-01
Completion date
2026-12-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature

Keywords

premature, Early intervention, orofacial stimulation, feeding difficulties, orality

Brief summary

The goal of this observational study is to assess the link between reactions to orofacial stimuli observed at 29 weeks of amenorrhoea, and feeding difficulties at 36 weeks of amenorrhoea, in babies born prematurely between 26 and 27 + 6 weeks of gestation, admitted to the CHSF between 1 May 2025 and 31 March 2026. The main questions it aims to answer are : Can reactions to orofacial stimulation in babies born very prematurely be used as a tool for early detection of feeding difficulties before discharge from hospital? Is it possible to establish a predictive score for potential feeding difficulties as early as 29 weeks of gestation corrected, based on reactions to orofacial stimuli ? Participants will have their reactions to orofacial stimulations recorded in the 'Suivi oralité' grid completed by the nurses in the neonatal medicine and intensive care unit, which will then collect.

Interventions

OTHEROro-facial stimulation

massages and sensory stimulation aimed at stimulating the oral-facial reflexes of newborns (hand-to-mouth connection, cardinal points, milk smell, digging, crushing (finger or teat), sucking (crushing + suction))

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 28 Weeks
Healthy volunteers
No

Inclusion criteria

* Premature babies born between 26 and 27 + 6 weeks of gestation * Admitted to the CHSF between 1 May 2025 and 31 March 2026 * Criteria grid completed upon admission * Parents or guardians informed of the study and not opposed to it.

Exclusion criteria

* ENT malformation * Neurological pathology * Dysplasia or oxygen therapy greater than or equal to 0.3L/min (these children are seen systematically) * Extreme prematurity (gestational age less than 26 weeks) * Genetic syndrome * Anoxic-ischaemic encephalopathy * Digestive malformation

Design outcomes

Primary

MeasureTime frameDescription
Enteral nutritionat 36 weeksNecessity for newborns to be fed exclusively by enteral nutrition at 36 weeks' gestation for at least 24 hours, percentage of milk volume taken orally at 36 weeks' gestation compared to prescription, average duration of bottle feeding at 36 weeks' gestation

Countries

France

Contacts

CONTACTHasinirina Hasinirina RAZAFIMAHEFA, MD
hasinirina.razafimahefa@chsf.fr+33
CONTACTCaroline TOURTE
caroline.tourte@chsf.fr1 61 69 31 50
PRINCIPAL_INVESTIGATORHasinirina RAZAFIMAHEFA, MD

Centre Hospitalier Sud Francilien

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026